MDx-Chex for BC-GP and BC-GN, new full-process, molecular diagnostics quality controls for bloodstream infections, receive FDA clearance
4 Oct 2023
Streck has recently announced that MDx-Chex® for BC-GP and MDx-Chex® for BC-GN, quality controls designed to verify the performance of the Luminex® VERIGENE® Blood Culture Gram-Positive (BC-GP) and Gram-Negative (BC-GN) tests for blood stream infection and sepsis, have been granted FDA clearance for use in diagnostic procedures.
MDx-Chex evaluates the analytical process of the Luminex VERIGENE tests, including cell lysis and DNA extraction, as well as DNA hybridization, detection and analysis. MDx-Chex can be used for assay verification, to track lot-to-lot performance of tests and to reduce the occurrence of incorrect results due to instrument or assay failures.
MDx-Chex for BC-GP and MDx-Chex for BC-GN cover targets tested with Luminex VERIGENE BC-GP and BC-GN within a single positive control tube, respectively. Because each control contains intact, inactivated microorganisms that are suspended in a matrix of stabilized red blood cells, white blood cells and blood culture media components, they can be run in the same manner as patient samples, reducing the risk of pre-analytical variables that may cause incorrect results.